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The Guidelines for Audiologic Screening were developed by the American Speech-Language-Hearing Association (ASHA) Panel on Audiologic Assessment and adopted as ASHA policy by the Legislative Council in November 1996 (LC19-96). Members of the Panel on Audiologic Assessment are Chie Craig, chair; pediatric working group: coordinator Deborah Hayes, with Kathryn Beauchaine, Stefanie Bronson, Robert Nozza, Anne Marie Tharpe, and Judith Widen; adult working group: coordinator Sabina Schwan, with Gary Jacobson and Wayne Olsen; Evelyn Cherow, ex officio; and Larry Higdon, Vice President for Professional Practices in Audiology, serving as the monitoring Executive Board officer.
These guidelines supersede the following ASHA policies and report:
American Speech-Language-Hearing Association. (1985, May). Guidelines for identification audiometry. Asha, 27, 49–53.
American Speech-Language-Hearing Association. (1989, March). Audiologic screening of newborn infants who are at risk for hearing impairment. Asha, 31, 89–92.
American Speech-Language-Hearing Association. (1990, April). Guidelines for screening for hearing impairment and middle-ear disorders. Asha, 32 (Suppl. 2), 17–24.
American Speech-Language-Hearing Association. (1992, August). Report: Considerations in screening adults/older persons for handicapping hearing impairment. Asha, 34, 81–87.
ASHA's strong commitment to the prevention and early detection of audiologic disorders is evidenced by Article II of the ASHA Bylaws that states: (one of) “the purposes of this organization shall be to … promote investigation and prevention of disorders of human communication.” Primary prevention includes altering susceptibility or reducing exposure to causes of hearing loss. Audiologic screening serves a secondary prevention function; that is, if a hearing disorder, impairment, or disability is detected and treated early, potential hearing-related problems can be prevented or ameliorated. Screening refers to a specific way to indicate need for further assessment for a disorder, impairment, or disability.
Several ASHA policy documents pertinent to audiologic screening in children and adults exist (ASHA, 1995). These guidelines and position statements are products of the efforts of several ASHA committees. Focused on screening for specific conditions or in specific populations, some of the extant guidelines continue to provide valuable information. A review of the documents, however, revealed that some guidelines overlapped, others needed updating and revision, and as a whole, the guidelines did not address audiologic screening across the life span (ASHA, 1985, 1989, 1990, 1991b; Joint Committee on Infant Hearing, 1994).
In 1993, the Ad Hoc Committee on Screening for Hearing Impairment, Handicap, and Middle Ear Disorders recommended the establishment of a mechanism within ASHA to “monitor screening guidelines and protocols for hearing impairment, disability, and middle ear disorders” (ASHA, 1995). As a result, ASHA established the Panel on Audiologic Assessment in 1995 with the following charge:
Review and update of pertinent ASHA policies and reports and the development of ASHA audiologic assessment and screening guidelines with consideration of traditional screening and diagnostic audiometry, auditory evoked potentials, otoacoustic emissions, and acoustic immittance procedures for pediatric and adult populations.
Based on previous committees' recommendations, current research findings, and changes in screening technology, the Panel determined that new, updated, and consolidated audiologic screening guidelines should be developed for all age groups and contained in a single document.
Early in its deliberations, the Panel agreed that, to maintain consistency across guidelines, important comprehensive design, development, and professional issues needed to be addressed. The Panel's preliminary discussions, therefore, focused on the following issues: (a) principles of screening; (b) test performance; (c) program development, management, and follow-up; (d) definitions of disorder, impairment, and disability; and (e) organizational framework. The following section contains the Panel's resolutions regarding each of these issues.
These ASHA screening guidelines represent the official policy of the Association and adhere to generally accepted principles for the detection of a disease (ASHA, 1995):
Purpose of Screening - The purpose of screening is to detect, among apparently healthy persons, those individuals who demonstrate a greater probability for having a disease or condition, so they may be referred for further evaluation.
Importance of the Disease - The greater the potential burden a disease represents to the individual and society, the greater the impetus to screen.
Diagnostic Criteria - For a screening program to be successful, there must be a clear and measurable definition of the disease one is attempting to identify through screening.
Treatment - Before a screening program is implemented, it is necessary to demonstrate that treatments are available, effective, and shown to alter the natural history of the disease.
Reaching Those Who Could Benefit - Screening programs are particularly valuable to those individuals who might benefit from early detection and intervention. Public policy can influence how well screening programs succeed in reaching the appropriate population.
Availability of Resources/Compliance - Effective and available diagnostic and treatment referral resources for the disease must be established prior to screening, as the value of screening depends on competent follow-up.
Appropriateness of the Test - Ideally a screening test should be easy to administer, comfortable for the patient, short in duration, and inexpensive. The test must also meet certain performance criteria; that is, it must be sensitive and specific.
Screening Program Evaluation - Screening programs can and should be evaluated. Any recommended protocol should be based on data that demonstrate that those who are identified through screening have better outcomes than those not screened. Program costs can be estimated.
Because persons involved in audiologic screening should be familiar with these screening principles, important relevant references with more detailed discussions are provided (ASHA, 1992, 1994; Cadman, Chambers, Feldman, & Sackett, 1984; Feightner, 1992; Frankenburg, 1974; Hyde, Davidson, & Alberti, 1991; Swets, 1988; Thorner & Remein, 1982; Turner, 1991, 1992a, 1992b; Turner & Cone-Wesson, 1992; Weinstein & Fineberg, 1980).
The appropriate selection of a screening test depends, in part, on the test's performance in separating those with the target condition from those without the target condition. Whatever screening test is selected, a single cutoff value (the test criterion) must be chosen. The outcome of the screening is one of two possibilities: pass or refer.
The Panel selected test criteria based on a number of factors. Tests usually produce scores over a range along a continuum (e.g., hearing thresholds vary along the dB HL scale, peak compensated admittance varies along the mmho scale), and often there is a region of possible scores for which a proportion of those with the disease overlaps with a proportion of those without the disease (Griner, Mayewski, Mashlin, & Greenland, 1981). Test criteria recommendations herein reflect a desire to find a test value that maximizes the performance of the test in identifying those with the disease while maintaining an acceptable rate of correctly identifying those without the disease.
To understand the screening process, it is necessary to understand how the performance of a screening test is estimated and how relevant variables interact. Also, the concepts of overlapping distributions and their relationship to sensitivity, specificity, prevalence, and predictive values need to be understood to evaluate test performance.
Sensitivity and specificity of a test relate to the ability of the test to identify correctly both those with the disease (sensitivity) and those without the disease (specificity). Sensitivity is the ratio of the number with the disease who are positive on the screening test to the number of all those with the disease. In other words, sensitivity represents the percentage labeled positive on the screening test of all those who truly have the target condition. Specificity is the ratio of the number of those without the disease who are negative on the screening test to the number of all those without the disease. In other words, specificity is the percentage labeled negative on the screening test of all those who truly are free of the target condition. To determine sensitivity and specificity, controlled clinical trials must be conducted. Screening results are compared to diagnostic test findings for verification of the patient's true status.
The overlapping distributions, and the resulting sensitivity and specificity, also provide information. That is, some individuals without the disease are referred for diagnosis and follow up (false-positive results) and some individuals with the disease are not referred (false-negative results). The false-positive rate (1 - specificity) and the false-negative rate (1 - sensitivity) depend on the degree of overlap of the two distributions on the continuum of test scores as well as the specific test criterion (i.e., cutoff) that is used.
The test performance (sensitivity and specificity) together with the percentage of the population with the disease (disease prevalence) determine predictive values and the rates of over- and under-referral for diagnosis. Positive and negative predictive values are ratios also. Positive predictive value (PPV) is the ratio of the number of those scoring positive on the test who truly have the disease to the number of all those who scored positive on the test. Negative predictive value (NPV) is the ratio of the number of those scoring negative who truly do not have the disease to the number of all those scoring negative on the test. They are functions of sensitivity and specificity as well as the prevalence of the target condition. Whereas sensitivity and specificity of the test remain constant as long as the condition screened and the test criterion remain constant, predictive values vary with disease prevalence. In that regard, an estimate of prevalence of the condition must be known in addition to the sensitivity and specificity of the chosen test.
Predictive values determine over-referral and under-referral rates. The over-referral rate is the proportion of those referred who do not have the disease (1-PPV), and the under-referral rate is the proportion of those not referred who do have the disease (1-NPV). An unacceptably high over-referral rate can cause dissatisfaction among those being screened as well as those to whom the referrals are sent; it thereby reduces the effectiveness of the program. A high under-referral rate, which means that those with a disease are not identified, is also problematic and often results in delayed diagnosis and related consequences.
One mechanism for avoiding the problem of a high over-referral rate is to increase the prevalence of disease in the population screened. This is done by identifying a subgroup within the population that is at greater risk for having the target condition than the larger general population. Identification of a high-risk group can reduce an otherwise unmanageable over-referral rate to manageable proportions. Of course, there is a cost to such a decision. By selecting a high-risk subgroup for screening, those in the unscreened group who truly have the condition will be missed.
The development of audiologic screening programs requires careful planning, implementation, and follow-up. Important program considerations include professional accountability and liability, risk management and quality improvement, and program evaluation.
Professional accountability and liability refer to the responsibility of the audiologist who develops, implements, and supervises the screening program to ensure appropriate patient care in all activities. These guidelines recommend that an audiologist be responsible for program accountability. Other personnel may perform the screening procedure (ASHA, 1981). Audiologists' responsibilities include developing mechanisms to ensure (a) patient confidentiality; (b) proper application of the screening protocol, including training and supervision of support personnel; and (c) appropriate patient counseling and referral.
These guidelines recommend obtaining informed consent, or, in the case of children, informed parental/legal guardian permission; however, extant state statutes or regulations, or institutional policies supersede this recommendation.
Risk management and quality assurance refer to the responsibility of the audiologist to evaluate risk factors associated with the screening program and to develop procedures to minimize or eliminate those factors. Risk factors in hearing screening programs may include potential for infection, inaccurate screening results based on equipment malfunction or errors in calibration, and errors in patient referral and follow-up. The audiologist is responsible for developing mechanisms to ensure (a) infection control through universal precautions (ASHA, 1991a; Ballachanda, Roeser, & Kemp, 1996; Joint Commission on Accreditation of Health Care Organizations, 1995; U.S. Department of Labor, Occupational Safety and Health Administration, 1991); (b) equipment calibration, electrical safety, and daily listening checks; and (c) accurate patient identification and recordkeeping. These quality assurance activities should include written documentation on a regular basis.
Program evaluation refers to the responsibility of the audiologist to evaluate the effectiveness of the screening program. This involves developing mechanisms to (a) quantify the pass and refer rates, (b) estimate the false-positive and false-negative rates, and (c) assure the effectiveness of follow-up protocols, especially for patients who are referred from the screening process. Program evaluation should occur on an ongoing basis to identify and correct factors that hinder optimum screening program performance and patient care.
The components of professional accountability and liability, risk management and quality assurance, and program evaluation must be developed prior to implementation of any screening program. Appropriate development of these components assists the audiologist in ensuring overall program quality and effectiveness.
Consistent with terminology previously defined in the Report on Audiologic Screening (ASHA, 1995), the Panel developed separate guidelines for screening of hearing disorder, impairment, and disability. The Panel specifically adopted the following discrete definitions:
Disorder is any anatomic abnormality or pathology. It may or may not result in a change in function of a given organ or organ system.
Impairment is any loss or abnormality of psychological or physiological function. It implies that some functional aspect of an organ, system, or mechanism is outside a normal range.
Disability is any restriction or lack of ability to perform an activity by an individual (resulting from an impairment).
The Panel also considered the term handicap as defined by the ASHA Committee on Screening for Hearing Impairment, Handicap, and Middle Ear Disorders (ASHA, 1995).
Handicap is the difficulty experienced by an individual as a result of an impairment or disability and as a function of barriers (e.g., communication, structural, architectural, attitudinal), lack of accommodations, and/or lack of appropriate auxiliary aids and services (e.g., amplified telephone handset, assistive listening device) required for effective communication.
The Panel concluded that due to federal initiatives (Americans With Disabilities Act, Individuals With Disabilities Education Act) and consumer preferences (ASHA, 1994), the term handicap had undergone a process of definitional evolution. According to the World Health Organization definition (World Health Organization, 1980), the term handicap refers to a conflict between the person's performance or status and the expectations of his or her particular reference group.
As currently defined, persons with disabilities may find themselves in handicapping situations due to specific environmental restrictions or social expectations. The Panel concluded that it is inappropriate, therefore, to identify a person as having a hearing handicap. The Panel decided to refrain from employing the term handicap except in the “Screening for Auditory Disability” adult section, where it is used in reference to previous research and specific screening instruments.
The Panel adhered to a comprehensive organizational framework upon which separate sets of updated and new audiologic screening guidelines for disorder, impairment, and/or disability across age span could be drafted. Each set of guideline materials contains a general introductory section, an outline of recommended guidelines, and a discussion of important issues related to the assumptions and rationale underlying the Panel's recommendations.
The Panel asserts that all elements of each set should be fully considered prior to implementation of any guideline. The Panel's outlines of recommended guidelines are organized in a manner consistent with the Preferred Practice Patterns for the Professions of Speech-Language Pathology and Audiology document (ASHA, 1993); that is, recommendations include Personnel, Expected Outcome(s), Clinical Indications, Clinical Process, Pass/Refer Criteria, Setting/Equipment Specifications, and Documentation.
The present document accommodates two major sections, one for screening protocols for pediatric noninstitutionalized populations and one for screening protocols for adult noninstitutionalized populations. Each section contains introductory materials that reflect some special concerns regarding those populations. The pediatric section accommodates five sets of guidelines. One set pertains to screening infants and children for outer and middle ear disorder, and the remaining four sets (newborn, infant-toddlers, pre-school, and school-age) address screening for impairment and disability.
The working group on screening adults developed three sets of guidelines: screening for disorder, screening for impairment, and screening for disability. Although each set is discrete, the panel strongly recommends that all three sets be implemented in adult audiologic screening programs.
These guidelines represent ASHA policy for audiologic screening practice, not standards. The Panel recognizes that each screening program and individual case represents unique characteristics that may influence the approach to screening program development and management and individual screening protocols. The Panel encourages audiologists to exercise professional judgment in the planning and implementation of screening programs.
American Speech-Language-Hearing Association. (1981, March). Guidelines for the employment and utilization of supportive personnel. Asha, 23, 165-169.
American Speech-Language-Hearing Association. (1985, May). Guidelines for identification audiometry. Asha, 27, 49-52.
American Speech-Language-Hearing Association. (1989, March). Audiologic screening of newborn infants who are at risk for hearing impairment. Asha, 31, 89-92.
American Speech-Language-Hearing Association. (1990, April). Guidelines for screening for hearing impairment and middle-ear disorders. Asha, 32(Suppl. 2), 17-24.
American Speech-Language-Hearing Association. (1991a). Chronic communicable diseases and risk management in the schools. Language, Speech, and Hearing Services in Schools, 22, 345-352.
American Speech-Language-Hearing Association. (1991b, March). Guidelines for the audiologic assessment of children from birth through 36 months of age. Asha, 33(Suppl. 5), 37-43.
American Speech-Language-Hearing Association. (1992, August). Report: Considerations in screening adults/older persons for handicapping hearing impairment. Asha, 34, 81-87.
American Speech-Language-Hearing Association. (1993). Preferred practice patterns for the professions of speech-language pathology and audiology. Asha, 35(Suppl. 11), 5-6.
American Speech-Language-Hearing Association. (1994, September). “Person first, please”. Asha, 36, 10.
American Speech-Language-Hearing Association. (1995, February). Report on audiological screening. American Journal of Audiology, 4, 24-40.
Ballachanda, B. B., Roeser, R. J., & Kemp, R. J. (1996). Control and prevention of disease transmission in audiology practice. American Journal of Audiology, 5(1), 74-82.
Cadman, D., Chambers, L., Feldman, W., & Sackett, D. (1984). Assessing the effectiveness of community screening programs. Journal of the American Medical Association, 252, 1580-1585.
Feightner, J. W. (1992). Screening in the 1990's: Some principles and guidelines. In Bess, F. H. & Hall, J. W. (Eds.), Screening children for auditory function (pp. 1-16). Nashville: Bill Wilkerson Center Press.
Frankenburg, W. K. (1974). Section of diseases and tests in pediatric screening. Pediatrics, 54, 612-616.
Griner, P. F., Mayewski, R. J., Mashlin, A. I., & Greenland, P. (1981). Selection and interpretation of diagnostic tests and procedures. Annals of Internal Medicine, 92, 557-570.
Hyde, M. L., Davidson, M. J., & Alberti, P. W. (1991). Auditory test strategy. In Jacobson, J. T. & Northern, J. L. (Eds.), Diagnostic audiology (pp. 295-322). Austin, TX: Pro-Ed.
Joint Commission on Accreditation of Health Care Organizations. (1995). Comprehensive accreditation manual for hospitals—Sect. 2, Surveillance, prevention, and control of infection. Oakbrook Terrace, IL: JCAHO.
Joint Committee on Infant Hearing. (1994, December). Position Statement. Asha, 36, 38-41.
Swets, J. (1988). Measuring the accuracy of diagnostic systems. Science, 240, 1285-1293.
Thorner, R. M., & Remein, Q. R. (1982). Principles and procedures in the evaluation of screening for disease. In Chaiklin, J. B., Ventry, I. M., & Dixon, R. F. (Eds.), Hearing measurement: A book of readings (2nd ed., pp. 408-421). Reading, MA: Addison-Wesley.
Turner, R. G. (1991). Making clinical decisions. In Rintelmann, W. F. (Ed.), Hearing assessment (2nd ed., pp. 679-739). Austin, TX: Pro-Ed.
Turner, R. G. (1992a). Comparison of four hearing screening protocols. Journal of the American Academy of Audiology, 3, 200-207.
Turner, R. G. (1992b). Factors that determine the cost and performance of early identification protocols. Journal of the American Academy of Audiology, 3, 233-241.
Turner, R. G., & Cone-Wesson, B. (1992). Prevalence rates and cost-effectiveness of risk factors. In Bess, F. H. & Hall, J. W. (Eds.), Screening children for auditory function (pp. 79-104). Nashville: Bill Wilkerson Center Press.
U.S. Department of Labor, Occupational Safety and Health Administration. (1991, December 6). Occupational exposure to bloodborne pathogens: Final rule. In Federal Register. Washington, DC.
Weinstein, M., & Fineberg, H. (1980). Clinical decision making. Philadelphia: Saunders.
World Health Organization (WHO). (1980). International classification of impairments, disabilities, and handicaps: A manual of classification relating to consequences of disease (pp. 25-43). World Health Organization.
The impact of childhood hearing impairment is well documented, particularly as it interferes with the development of speech and verbal language skills (Allen, 1986; Davis, 1988; Osberger, Moeller, Eccarius, Robbins, & Johnson, 1986; Osberger, Robbins, Lybolt, Kent, & Peters, 1986). Hearing impairment adversely affects the developing auditory nervous system and can have harmful effects on social, emotional, cognitive, and academic development, and, subsequently, on the individual's vocational and economic potential (Downs, 1994; Gravel, Wallace, & Ruben, 1995, 1996; National Institutes of Health, 1993).
The incidence of newborn hearing impairment is estimated to range from 1.5 to 6.0 per 1,000 live births (Parving, 1993; Watkin, Baldwin, & McEnery, 1991; White & Behrens, 1993). The prevalence rises in older infants and toddlers if mild conductive hearing losses associated with otitis media with effusion are included in the estimates. The most important period for language and speech development occurs during the first 3 years of life, but despite methods for identifying hearing impairment in newborns, the average age of identification in the United States continues to exceed 12 months (Harrison & Roush, 1996). Milder hearing impairments may go undetected even longer. It has become a national goal to reduce the age of identification to the first few months of life (Joint Committee on Infant Hearing, 1994; U.S. Department of Health and Human Services, Public Health Service, 1990).
Recent evidence indicates that the earlier impairment is identified and treatment begun, the greater the likelihood of preventing or reducing the debilitating/disabling effects that can result (Appuzo & Yoshinaga-Itano, 1995). Even children with unilateral hearing impairment remain at-risk for adverse academic and social-emotional effects (Bess, Klee, & Culbertson, 1986; Bess & Tharpe, 1986; Culbertson & Gilbert, 1986; Klee & Davis-Dansky, 1986; Oyler, Oyler, & Matkin, 1987, 1988). Children throughout the age range of birth through 18 years should receive hearing screening to detect congenital and/or acquired hearing impairment that may interfere with health, development, communication, and/or education.
Although hearing disorder, impairment, and/or disability are prevalent among infants and children, a comprehensive set of screening guidelines for this population did not previously exist within a single document. This pediatric section contains audiologic screening guidelines that pertain to infants and children age birth through 18 years who have not been previously identified as having a hearing disorder, impairment, and/or disability, and to infants and children who can participate appropriately in the recommended process.
In the development of these audiologic screening guidelines, the Panel considered existing guidelines (ASHA, 1985, 1989, 1990, 1991, 1993). In these new guidelines that supersede previous ASHA screening guidelines, the Panel has attempted to synthesize current knowledge and to recommend appropriate clinical practice for children of all ages.
The Panel developed separate pediatric guidelines for hearing disorder and hearing impairment based on chronological age and developmental abilities:
Guidelines for screening for outer and middle ear disorder among older infants and children.
Guidelines for screening for hearing impairment among:
newborns and infants age birth through 6 months
infants and toddlers age 7 months through 2 years
preschool children age 3 to 5 years
school-age children age 5 through 18 years.
Children of all ages can receive reliable and valid screening for hearing impairment. For infants whose developmental age does not correspond with their chronological age (e.g., infants with developmental disabilities, infants who were born prematurely), the screening procedure selected should be appropriate to the child's developmental abilities.
Screening for hearing disability in children should be included in a general developmental screening of any child. In these sets of guidelines, screening for hearing disability is discussed below.
Screening infants and children for hearing disorder and hearing impairment requires considerable professional expertise and technological sophistication. The Panel recommends that the screening process be designed, implemented, and supervised by an audiologist with the Certificate of Clinical Competence (CCC-A) from ASHA, and state licensure where applicable. Those cases where audiology support personnel may augment the audiologist's services are indicated in each guideline.
These guidelines recommend obtaining informed parental/legal guardian permission; however, extant state statutes or regulations, or institutional policies, supersede this recommendation. Protocols should be developed that ensure patient confidentiality. The permission of the patient/legal guardian is the basic legal requisite necessary for disclosure of screening results to third parties (e.g., treatment programs or other professionals or agencies). The infant's or child's name should not be released without written permission of the parent(s) or guardian, the child's consent when he or she reaches the age of majority, or a court order (Andrews, 1985; Tharpe & Clayton, in press).
Allen, T. (1986). Patterns of academic achievement among hearing impaired students: 1974 and 1983. In Schildroth, A. & Karchmer, M. (Eds.), Deaf children in America (pp. 161-206). San Diego: College-Hill Press.
American Speech-Language-Hearing Association. (1985, May). Guidelines for identification audiometry. Asha, 27, 49-53.
American Speech-Language-Hearing Association. (1989, March). Audiologic screening of newborn infants who are at risk for hearing impairment. Asha, 31, 89-92.
American Speech-Language-Hearing Association. (1990, April). Guidelines for screening for hearing impairment and middle-ear disorders. Asha, 32(Suppl. 2), 17-24.
American Speech-Language-Hearing Association. (1991, March). Guidelines for the audiologic assessment of children from birth through 36 months of age. Asha, 33(Suppl. 5), 37-43.
American Speech-Language-Hearing Association. (1993, March). Preferred practice patterns for the professions of speech-language pathology and audiology. Asha, 35(Suppl. 11), 1-102.
Andrews, L. B. (Ed.). (1985). Legal liability and quality assurance in newborn screening. Chicago: American Bar Foundation.
Apuzzo, M. L., & Yoshinaga-Itano, C. (1995). Early identification of infants with significant hearing loss and the Minnesota Child Development Inventory. Seminars in Hearing, 16, 124-139.
Bess, F. H., Klee, T., & Culbertson, J. L. (1986). Identification, assessment, and management of children with unilateral sensorineural hearing loss. Ear and Hearing, 7, 43-51.
Bess, F. H., & Tharpe, A. M. (1986). Case history data on unilaterally hearing-impaired children. Ear and Hearing, 7, 14-19.
Culbertson, J., & Gilbert, L. (1986). Children with unilateral sensorineural hearing loss: Cognitive, academic, and social development. Ear and Hearing, 7, 38-42.
Davis, J. M. (1988). Management of the school age child: A psychosocial perspective. In Bess, F. (Ed.), Hearing impairment in children (pp. 401-416). Parkton, MD: York Press.
Downs, M. P. (1994). The case for detection and intervention at birth. Seminars in Hearing, 15, 76-83.
Gravel, J. S., Wallace, I. F., & Ruben, R. J. (1995). Early otitis media and later educational risk. Acta Otolaryngologica (Stockholm), 115, 279-281.
Gravel, J. S., Wallace, I. F., & Ruben, R. J. (1996). Auditory consequences of early mild hearing loss associated with otitis media. Acta Otolaryngologica (Stockholm), 116, 219-221.
Harrison, M., & Roush, J. (1996). Age of suspicion, identification, and intervention for infants and young children with hearing loss: A national survey. Ear and Hearing, 17, 55-62.
Joint Committee on Infant Hearing. (1994). Position statement. Asha, 36, 38-41.
Klee, T., & Davis-Dansky, E. (1986). A comparison of unilaterally hearing-impaired children and normal-hearing children on a battery of standardized language tests. Ear and Hearing, 7, 27-37.
National Institutes of Health. (1993). Early identification of hearing impairment in infants and young children: Consensus development conference. Bethesda, MD: NIH.
Osberger, M., Moeller, M., Eccarius, M., Robbins, A., & Johnson, D. (1986). Expressive language skills. In Osberger, M. (Ed.), Language and learning skills in hearing impaired students. In Osberger, M. (Ed.), ASHA Monographs (Vol. 23, pp. 54-65).
Osberger, M., Robbins, A., Lybolt, J., Kent, R., & Peters, J. (1986). Speech evaluation. In Osberger, M. (Ed.), Language and learning skills in hearing impaired students. In Osberger, M. (Ed.), ASHA Monographs (Vol. 23, pp. 24-31).
Oyler, R. F., Oyler, A. L., & Matkin, N. D. (1987). Warning: A unilateral hearing loss may be detrimental to a child's academic career. Hearing Journal, 40(9), 18-22.
Oyler, R. F., Oyler, A. L., & Matkin, N. D. (1988). Unilateral hearing loss: Demographics and educational impact. Language, Speech, and Hearing Services in Schools, 19, 201-210.
Parving, A. (1993, May). Congenital hearing disability—Epidemiology and identification: A comparison between two health authority districts. International Journal of Pediatric Otorhinolaryngology, 27(1), 26-46.
Tharpe, A. M., & Clayton, E. W. (in press). Newborn hearing screening: Issues in legal liability and quality assurance. American Journal of Audiology.
U.S. Department of Health and Human Services, Public Health Service. (1990). Healthy people 2000: National health promotion and disease prevention objectives. Washington, DC: U.S. Government Printing Office.
Watkin, P. M., Baldwin, M., & McEnery, G. (1991, October). Neonatal at risk screening and the identification of deafness. Archives of Disease in Childhood, 66(10 Spec. No.), 1130-1135.
The Rhode Island Hearing Assessment Project: Implications for universal newborn hearing screening. In White, K. R. & Behrens, T. R. (Eds.), Seminars in Hearing (Vol. 14, pp. 1-122).
The issue of whether mass (universal) screening for middle ear disease is desirable or necessary continues to be debated (Bess, 1980; Bluestone et al., 1986; Lim, 1989; Lous, 1995; Northern, 1980; Task Force of the Symposium on Impedance Screening for Children, 1978) and must be resolved by the program administrator(s) based on circumstances specific to the goals of a given screening program. Many opposed to universal screening have argued that identification of high risk groups is a more cost effective and efficient means of identifying the majority of those who will have chronic middle ear disease. In that regard, no position on mass (universal) screening for middle ear disease is offered or implied in these guidelines.
The primary goal of outer and middle ear screening is to identify children with chronic otitis media with effusion (OME) that has the potential to cause significant medical problems, hearing loss, and/or long-lasting speech, language, and learning deficits. However, the Panel is aware that many complex and controversial issues related to screening for middle ear disease remain unresolved (Bluestone et al., 1986). Some of the issues were debated by large groups of experts in 1977 (Bess, 1980; Northern, 1980; Task Force of the Symposium on Impedance Screening for Children, 1978) and again in 1984 (Bluestone et al., 1986). Concerns specifically related to screening for otitis media with effusion were addressed in the Report of the Fourth Research Conference on Otitis Media in 1987 (Lim, 1989).
The Panel concluded that identification of outer and middle ear disease is critical; it is a disease with high prevalence (U.S. Department of Health and Human Services, 1994) and high cost in terms of diagnosis and treatment, and has significant morbidity for a small percentage of those who have it. Despite the controversies and questions, there is general consensus that chronic middle ear disease in early childhood is a potentially significant disease that can have both medical and developmental consequences and that it should be identified and treated.
To screen children for outer and middle ear disorders, the Panel developed a single set of guidelines to apply across the pediatric age span. Screening for outer and middle ear disorders is essentially the same for all ages. It involves a pass/refer procedure to identify those children at risk for significant outer and middle ear disorders that have been undetected or untreated. The clinical process includes an optional case history, visual examination, and acoustic immittance testing.
Currently available instruments permit accurate detection of outer and middle ear disorders in the age range approximately 7 months through 18 years. Because the performance of acoustic immittance testing in identifying middle ear effusion (MEE) in young infants remains controversial, and access to that age group is limited to primary care physicians, the Panel refrained from developing guidelines that address screening for disorder in younger infants. In those cases, the Panel recommends that screening for outer and middle ear disorders be part of all well-baby examinations conducted by primary care practitioners (Lim, 1989).
Previously, ASHA (1979, 1990) produced two sets of guidelines related to screening for middle ear disorders. The original ASHA guidelines for screening for middle ear disorders (ASHA, 1979) included the acoustic immittance measures of tympanometry and the acoustic reflex. Unfortunately, that protocol resulted in high over-referral rates and was consequently rejected by professionals to whom children were referred, by parents and by school systems. In 1990, ASHA published a set of revised guidelines that were designed to (a) reduce the over-referral rate that accompanied the previous guidelines, (b) expand the scope of the screening beyond acoustic immittance alone, and (c) introduce a more objective quantitative, as opposed to the previous qualitative, approach to tympanogram interpretation. The Panel recognizes that since the 1990 guidelines were developed, relevant new knowledge and experience have become available.
The outline presented below contains the Panel's recommended guidelines for the development, supervision, and delivery of screening programs for outer and middle ear disorders in pediatric populations. The Panel provides a discussion of issues related to the rationale and assumptions underlying the recommendations. The Panel urges that this discussion section be considered fully prior to the implementation of the recommendations.
Screening practitioners should be limited to:
Audiologists with Certificate of Clinical Competence (CCC-A) from the American Speech-Language-Hearing Association (ASHA) and state licensure where applicable (ASHA, 1996a).
Speech-language pathologists with Certificate of Clinical Competence (CCC-SLP) from the American Speech-Language-Hearing Association (ASHA) and state licensure where applicable (ASHA, 1996b).
Support personnel under supervision of a certified audiologist (ASHA, 1981).
Identification of infants and children most likely to have:
Outer and middle ear conditions that may result in hearing loss or that may have significant health or developmental consequences.
Chronic or recurrent outer and middle ear disease.
Screen infants and children for outer and middle ear disorders as needed, requested, or mandated, or when they have conditions that place them at risk.
Screen infants and children from 7 months through 6 years of age. In the event that all of these children cannot be screened, it is recommended that children with the following characteristics be screened (Bluestone & Klein, 1996):
A first episode of acute otitis media prior to 6 months of age,
Infants who have been bottle fed,
Children with craniofacial anomalies, stigmata, or other findings associated with syndromes known to affect the outer and middle ear,
Ethnic populations with documented increased incidence of outer and middle ear disease (e.g., Native American and Eskimo populations),
A family history of chronic or recurrent OME,
Those in group day care settings and/or crowded living conditions,
Those exposed to excessive cigarette smoke, and
Children diagnosed with sensorineural hearing loss (Pappas, 1985), learning disabilities, behavior disorders, or developmental delays and disorders.
For children between 7 months and 6 years of age, screen for outer and middle ear disorders (Gates et al., 1989).
Conduct the first regularly scheduled screening program in the fall in conjunction with screening for hearing impairment (see age-appropriate guideline).
Conduct a second regularly scheduled screening program for those who failed or were missed in the fall.
Note that infants and children under the care of a physician for middle ear disorder need not participate in a screening program.
Note that infants and children not enrolled in organized child care programs, such as Head Start, should be screened for disorder at routine well-baby visits by primary care practitioners. (This type of screening is not within the scope of this document).
These guidelines recommend obtaining informed parental/legal guardian permission; however, extant state statutes or regulations, or institutional policies, supersede this recommendation.
Conduct screenings in a manner congruent with infection control and universal precautions (Ballachanda, Roeser, & Kemp, 1996; U.S. Department of Labor, Occupational Safety and Health Administration, 1991).
When possible, obtain a case history through verbal report of parent or guardian.
Visually inspect the ears to identify risk factors for outer and middle ear disease, and to ensure that no contraindications exist for performing tympanometry (e.g., drainage, foreign bodies, tympanostomy tubes).
As training and scope of practice (ASHA 1996b) permit, use a lighted otoscope or video-otoscope to examine the external ear canal and tympanic membrane (TM) for obvious obstructions or structural defects.
As training and scope of practice (ASHA 1996b) permit, perform tympanometry with a low frequency (220, 226 Hz) probe tone and a positive to negative air pressure sweep.
All hearing screening programs should include an educational component designed to provide parents with information, in lay language, on the process of ear disorder screening, the likelihood of their child having an ear disorder, and follow-up procedures.
Pass if no positive result exists for test criteria in both ears.
Refer for medical examination of the ears if:
ear drainage is observed.
visual identification of previously undetected structural defect(s) of ear occurs.
ear canal abnormalities such as obstructions, impacted cerumen or foreign objects, blood or other secretions, stenosis or atresia, otitis externa, and perforations or other abnormalities of the tympanic membrane are apparent.
tympanometric equivalent ear canal volume (Vec) is greater than 1.0 cm3 accompanied by a flat tympanogram (i.e., there is no admittance peak) to select those at risk for TM perforation. Do not refer if tympanostomy tube is in place or a perforation of the TM is under management of a physician. See Table 2.1.1 for estimates of a normal range for Vec, assuming compensation for ear canal volume at +200 daPa.
follow-up tympanometric screening (i.e., rescreen) test results are outside the test criteria presented in Table 2.1.2. Because prevalence of middle ear disorders in the group referred for rescreening is often greater than in the group screened initially, screening program administrators may consider modifying pass/refer criteria to optimize program performance (see discussion).
Refer for rescreening if:
initial tympanometric screening test results are outside test cutoffs as presented in Table 2.1.2.
Be aware that the recommended test criteria may need to be adjusted based on important factors specific to each individual program (See Discussion).
Note that pathologies that increase admittance of the middle ear (e.g., ossicular discontinuity) will not be identified.
The following are not recommended:
pure-tone hearing screening to identify those at risk for outer or middle ear disease;
otoscopic examination alone for identification of those at risk for outer or middle ear disease;
acoustic reflectometry;
tympanometric peak pressure (TPP);
acoustic reflex tests; and
otoacoustic emissions screening measures.
Based on review of the supervising audiologist, the following recommendations may be made:
Recommend immediate medical evaluation for child referred due to:
case history (if completed), visual inspection or otoscopic screening results demonstrating otalgia or otorrhea; and
tympanometric equivalent ear canal volume (Vec) and flat tympanogram results indicating TM perforation(s).
Rescreen child referred based on criteria in Table 2.1.2 within 6 to 8 weeks from the time of the initial test.
Recommend immediate medical evaluation for the child when rescreening results continue to indicate an abnormality.
Communicate promptly with parents or other caretakers and make a medical referral to, in most cases, the family physician.
Request information regarding the outcome of follow-up audiological evaluations or medical examinations. The supervising audiologist should monitor, and may participate in, the management of the child.
Screen in an environment conducive to tympanometry and lighted otoscopy.
Use a lighted otoscope or video-otoscope.
Use a screening or diagnostic tympanometer. Note that some instruments are restricted for certain test parameters, so the influence of different instrumentation settings on tympanometric measures must be considered.
Meet American National Standards Institute specifications for instruments to measure aural acoustic impedance and admittance (aural acoustic immittance) (ANSI S3.39-1987).
Meet manufacturer's specification for calibration and regulatory agency specification of equipment for electrical safety.
Record identifying information, screening/rescreening results, and recommended followup procedures. Include names of personnel conducting the screening/rescreening.
Record case history (if completed), otoscopic and tympanometric results.
Document follow-up results and personnel conducting follow-up.
Epidemiological studies indicate that prevalence of MEE increases through the winter months; thus, one might argue for screening during that time of the year. However, a high percentage of the cases of OME during the winter are associated with upper respiratory tract infections (URI). The need to aggressively seek out such episodes of OME is small because children with URI often receive medical attention, and OME associated with URI often resolves with resolution of the URI (Gates et al., 1989). Some underserved populations, however, may not get medical attention promptly even for URI, so screening during seasons of high incidence and prevalence is indicated.
It is not cost effective to screen the general population of children 7 years of age and older because the potential yield is very low (Lous, 1995; Gates et al., 1989). However, some groups of children are at increased risk for OME or are especially vulnerable to effects of auditory disorders. Individual program administrators may choose to screen such children after they are 7 years of age. Populations considered to be at greater risk for OME include those of certain ethnic backgrounds such as Native American and Eskimo, those who live in crowded conditions, those with craniofacial anomalies, stigmata, or other findings or syndromes associated with otitis media with effusion, and possibly those exposed to cigarette smoke in the home. In addition, children with sensorineural hearing impairment, learning disabilities, and other conditions that might affect learning should continue to be screened for middle ear disorders throughout the school years.
In the previous Guidelines (ASHA, 1990), case history and visual inspection were recommended as possible ways to reduce over-referrals that result from tympanometric screening. Despite the paucity of data on the efficacy of case history and/or screening by visual examination, this Panel recommends also that screening programs include such measures. Programs that develop mechanisms for screening using case history and/or visual examination are encouraged to collect and share information on efficacy of these measures.
Tympanometric equivalent ear canal volume (Vec) outside the normal range accompanied by a tympanogram with no peak may indicate an opening in the TM. Unless a child has a tympanotomy tube in place or is known to have a TM perforation that is under management of a physician, an immediate referral for medical examination is indicated.
Tympanometric criteria for referral when screening for MEE vary depending on factors related to the population screened, such as age and prevalence of middle ear disease, as well as resources for follow-up and factors related to instrumentation settings. Factors related to the population, the test parameters, the disease as defined by the screening program administrators, and the availability of diagnostic referral resources also affect the choice of a referral criterion (Nozza, 1995).
Tympanometric peak pressure (TPP) is not included in the criteria for identifying children at risk for OME. TPP was excluded from the guidelines developed by ASHA in 1990. It was stated that “…negative TPP associated with an otherwise normal tympanogram is a poor determinant of middle ear effusion. Furthermore, abnormal TPP in the absence of other tympanic membrane abnormalities does not reflect a change in the mechanical properties of the middle ear…” Wiley and Smith (1995) in reviewing TPP in screening report that “…its use in middle ear screening results in poor specificity or high false positive rates.” New data on performance of tympanometric variables for identifying MEE have been reported (Nozza et al., 1992; 1994, Silman, Silverman, & Arick, 1992). Although Silman et al. (1992) recommend test criteria that include TPP, Nozza et al. (1992, 1994) found TPP to be of little value in identifying ears with middle ear effusion.
In the absence of data, an alternative method based on the limits of the normal range may be used to determine screening test criteria. For infants above 7 months with normal middle ear function, the 5th percentile for peak compensated static acoustic admittance (Ytm) is 0.2 mmho, so one choice for a test criterion would be <0.2 mmho (Roush et al., 1995). In that case, specificity is set to 95% because only 5% of normal ears would be below the cutoff value. In a similar way, tympanometric width (TW)>235 daPa would have 95% specificity because 235 daPa is at the 95th percentile of normal ears (Roush et al., 1995). However, when using data from normal ears to select a screening criterion, information on the distribution of test scores for abnormal ears is lacking, so no estimate of sensitivity can be made. A screening program that relies on criteria determined using only normative data must monitor program performance carefully and use information on program outcomes to modify screening test criteria, if necessary.
For infants and children from 1 year to school age, Ytm<0.3 mmho or TW>200 daPa are recommended screening criteria. These values have been shown to be just outside the normal range for infants under 30 months (Roush et al., 1995) and also have been shown to have high specificity and good sensitivity in children of school age (Nozza, 1995; Nozza et al., 1994; Silman, Silverman, & Arick, 1992, 1994). These values are slightly different from those reported in the 1990 ASHA guidelines [i.e., Ytm<0.2 mmho or TW>150 daPa], which were based on normative data from children 4 to 6 years of age. The new recommended cutoffs should produce greater specificity with only negligible adverse effects on sensitivity in screening programs that address unselected groups of children in the general population such as might attend preschools or elementary schools. In a low prevalence disease that has nonlethal sequelae and for which over-referrals can be a problem, maximizing specificity is considered desirable (Gates et al., 1989).
It has been shown that in a very high-risk group of children, that is, with a history of chronic MEE and scheduled for myringotomy and tube surgery, the criteria Ytm<0.2 or TW>300 have high sensitivity and specificity (Nozza et al., 1994). Obviously, the children undergoing surgery are the extreme cases in terms of OME severity. For groups of children who are at greater risk than the general population but who do not meet criteria for myringotomy and tube surgery, a slightly different criterion might serve better. As stated above, by monitoring screening program outcomes, program administrators can adjust test criteria to reach satisfactory pass and refer rates.
The recommended criteria offered in this document are considered to be first approximations for the situations described. The recommended criteria for infants 6 to 12 months of age are based on limited data. For older children, there are more complete data. The cutoffs of Ytm<0.3 mmho or TW>200 daPa should serve well for programs involving children from the general population. For programs with children at greater risk for chronic or recurrent OME, that is, with higher prevalence of OME and/or more severe cases, different criteria might be necessary to keep over-referral rates to manageable proportions.
This guideline recommends that a child with unilateral or bilateral tympanogram meeting referral criteria other than those that are consistent with a TM perforation should be rescreened 6 to 8 weeks after the initial test. Because middle ear disease is often self-limiting, referral based on a single screening is generally not recommended. Various schemes for a two-screening protocol have been suggested (see ASHA, 1979; Lous, 1983; Northern, 1992; Roush, 1990 for additional information on retest criteria). Most suggested screen-rescreen protocols attempt on the first screening to identify a group at risk from the general population being screened. Then the rescreening, usually at about 6 or 8 weeks following the initial screening, is administered to further separate those with a high probability of chronic middle ear disease from those with transient disease. The screening criteria recommended above for infants and children in the general population are based on an assumption that the initial screening is of a group of children for whom the prevalence of middle ear disease is fairly low. The initial screening pass/refer criteria are designed to have high sensitivity with the understanding that specificity might be low; that is, on retest there will probably be many who will pass.
Pure-tone hearing screening to identify those at risk for outer or middle ear disease is not recommended. There are no data available that report reasonable specificity for a hearing screening for identification of those at risk for middle ear disease. Silman, Silverman, and Arick (1994) and Silverman (1995) have reported recently that hearing impairment screening had good sensitivity for identification of ears with MEE. However, they report no specificity data, so the Panel does not feel that this information can be used to justify a change in the screening protocol recommendation at this time.
Otoscopic inspection alone for identification of those at risk for middle ear disease is not recommended. Identification of MEE using an otoscope requires training and skill beyond that available to most programs designed to screen for middle ear disease. The visual inspection component of the screening guidelines is not intended to suggest that pass/refer decisions be made based on identification of middle ear disease. Rather, the intent is to use visual inspection as a means to identify gross abnormalities of the outer ear that would require immediate medical examination.
Acoustic reflectometry has not proven to have sufficient performance characteristics (sensitivity, specificity, and predictive ability) to be recommended for use in screening protocols. Whereas the potential for this instrument to provide an easy and quick screening for middle ear disease has been reported, research has not demonstrated efficacy of that procedure. At the time of this writing, there is no commercially available instrument for acoustic reflectometry testing for purposes of clinical assessment or screening.
The acoustic reflex test is associated with a high probability of false-positive identifications and questionable validity, especially when using automated instruments such as those used in many large screening programs. Failure to elicit an acoustic reflex is considered a positive result when the acoustic reflex is used in screening for middle ear disorder. To consider the absence of the acoustic reflex as positive assumes auditory function sufficient to produce an acoustic reflex in the absence of middle ear disease and integrity of all of the components of a reflex arc involving the cranial nerves VII and VIII. Some researchers have reported good performance of the acoustic reflex, under specific test conditions and population characteristics, and have suggested further research in that area (e.g., Silman & Emmer, 1995; Silman, Silverman, & Arick, 1992). However, the false positive rates reported for screening with the acoustic reflex have consistently been high (Lous, 1983; Nozza et al., 1992; Roush & Tait, 1985). Also, children with sensorineural hearing impairment and those with possible neurological problems that may interfere with the acoustic reflex arc must be screened also, but they would not be eligible for a screening that includes the acoustic reflex. That is, a screening test that is more directly related to the function being screened is favored. The acoustic reflex test is not recommended for screening for middle ear disorders.
Otoacoustic emissions testing holds promise for screening young children for hearing loss. It has also been suggested that such testing might be useful for identifying those at risk for middle ear disorders as well (Decreton, Hanssens, & DeSlooveres, 1991; Nozza & Sabo, 1992). However, there are too few data available regarding this test for screening infants and children to demonstrate efficacy at this time.
Either a screening or diagnostic tympanometer may be used. Some instruments are restricted for certain test parameters, so the influence of different instrumentation parameters on tympanometric measures must be considered. It is also important to remember that values such as Ytm are influenced by instrumentation settings. Most notably, the air pressure used for compensation of ear canal volume and the rate of pressure sweep can both affect the tympanometric data. The recommended criteria are based on data from different studies that have used different instrumentation settings (ASHA, 1990; Nozza et al., 1994). Program administrators responsible for setting protocols should be aware of the data on test performance and how the data were obtained.
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American Speech-Language-Hearing Association. (1990, April). Guidelines for screening for hearing impairments and middle ear disorders. Asha, 32(Suppl. 2), 17-24.
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